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Chronic Hepatitis B Studies
Principal Investigator: Dr. Maurizio Bonacini
Quest Clinical Research is currently enrolling three “proof of cure” studies for patients with Chronic Hepatitis B
GSK Study
Sponsored by GSK, evaluates Bepirovirsen (antisense oligonucleotide) administered subcutaneously (SQ) over 24 weeks followed by 24 weeks of follow-up with the possibility of then stopping NAs to determine the loss of HBsAg.

•   Demonstrated a 25% functional cure (HBsAg negative) rate in select patients with CHB (NEJM, Nov 2022)

•   This is a phase 3 study enrolling more than 1,000 patients

See the article  "Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection"  ~ the New England Journal of Medicine.
Roche Study
Sponsored by Roche, uses a long-acting monoclonal antibody (anti-HBs) which aims at neutralizing circulating- and virus-associated HBsAg, thereby increasing cellular immunity against the HBV virus.

•   This is an open label dose-escalating study in which patients will receive 1 dose of study drug at Day 1 and then continue to be followed for 24 weeks or until HBsAg returns to baseline.

 
Virion Study
Sponsored by Virion Therapeutics, evaluates T-cell immunotherapy (VRON-020, a therapeutic vaccine) which demonstrated a 3-log decrease in plasma viremia correlated with increased intrahepatic CD8+ T-cell activity following a single dose in a mouse model.

•   This study is a randomized study looking at 2 different doses of 2 vectors given IM @ Day 1 with a possibility of receiving a booster @ Day 91.

• 15 visits spread out over 1 year

 
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or Call Dr. Jay

415-353-0800

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